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SMA Policy Committee: overview of the problem

Bioethics and Anthropology: A Call for Partnership

Kathleen M. MacQueen, PhD, MPH
Family Health International, Durham, NC


Expenditures on clinical trials research have risen dramatically over the past decade, with an increasing proportion of trials being conducted in developing countries where access to health care and government oversight of research are limited to nonexistent.(1) Concerns have been voiced that vulnerable populations are being exploited for benefits that accrue to people elsewhere, initially spurred by controversies surrounding U.S. sponsored clinical trials in Africa and Asia to prevent the transmission of HIV from mothers to children.(2-4) A major ethical dilemma has emerged: how do we protect against exploitation without unduly constraining much-needed health research that could, in fact, benefit vulnerable populations?

Addressing this ethical dilemma has led to new conceptions of distributive and procedural justice in health research that emphasize the importance of ensuring that research is responsive to local needs, that populations targeted for study recruitment will ultimately benefit from the study results, and that consent to participate is truly voluntary and informed. There is also increasing pressure to ensure that research results can be, and are, effectively translated into health programs.(5;6) Awareness is emerging of the contribution of social, political, and economic factors to the pivotal relationship between health researchers and the people with whom they conduct their research.(7)

Anthropologists are ideally positioned to make important contributions to resolving the ethical dilemmas now confronting biomedical researchers. First, cultural anthropology provides an ideal base from which to contribute to the development and evaluation of culturally appropriate processes of informed consent. There is growing recognition of the fact that too much emphasis has been placed on written documentation that serves legalistic purposes, and not enough on assuring that the interaction between researchers and participants supports autonomous decision-making on the part of participants.(5;6) There is a need for both basic and applied research that goes beyond simplistic notions of cultural sensitivity and relativity(8) to substantive considerations of cultural heterogeneity, the moral and power dimensions of relationships, and the interplay between context and notions of coercion, inducement, and voluntariness.(9;10) Communities, not just research participants, need to be educated about key concepts in clinical trials research such as control arms, treatment arms, placebos, randomization, adverse events, and side effects, as well as related ethical concepts such as researcher obligations to participants and participant rights to redress should harm occur.(11;12) These are complex concepts with which even researchers at times struggle, and they warrant broader efforts at community education as part of the overall informed consent process.

Second, there is a strong base within anthropology for the development of participatory models for community involvement from which to develop approaches that are appropriate for the conduct of clinical trials. Currently, the most common model used by clinical researchers to engage local communities is community consultation, usually in the form of a community advisory board that may or may not include research participants. There is pressure for developing more meaningful partnerships with local communities that include decision-making authority as well as consultative input.(13) At the same time, global standards for the conduct of clinical research are increasingly rigorous. Reconciling the push for a participatory ethic with established roles, responsibilities, and accountability in high risk clinical research presents a daunting challenge that has received little formal attention. There is a critical need for systematic analyses of existing partnerships to identify strengths and weaknesses, as well as to provide data for developing improved models to support effective, participatory health research.

A third contribution is the potential role of anthropologists in monitoring local responses to clinical trials among individuals targeted for participation, within the communities where research takes place, and at political levels that cross-cut communities affected by the research process. For example, anthropologists can lead the way in assessments of individual-, family-, and community-level impacts of research on health care and quality of life. To adequately address the ethical issue of justice, techniques are needed for framing the risks and benefits of research more fully with reference to the social, political, and eocnomic contexts within which the research is embedded.(7;14)

In all these areas anthropologists can contribute to the development of models to assist stakeholders in their efforts to balance concerns at multiple levels from the local to the global. Researchers, sponsors, and host communities face practical challenges in each of the areas outlined above. Ethical guidance is evolving, often on the basis of anecdotal evidence and hearsay. As anthropologists we have an important opportunity to ensure that the ethical discourse in biomedical research is grounded in a substantive understanding of the full complexity and diversity of the human condition.

There is thus both an opportunity and an urgent need for anthropologists to get involved in these issues. In coming weeks the Society for Medical Anthropology will post a series of case studies on its web site to illustrate many of these challenges. A list of background readings has already been posted that outline the thorny nature of the complexly intertwined problems surrounding clinical trials research in developing countries. We invite the SMA membership to consider what we, as anthropologists, can contribute to their resolution, whether other issues need to be articulated, and how we can construct our role to have the greatest beneficial impact. As a starting point, SMA will establish a series of discussion groups, both virtual (web and email based) and real (in the context of the AAA and SfAA meetings). From these groups we hope to foster a coherent, viable, and effective partnership between anthropology and bioethics.

Reference List

  1. Office of Inspector General, Department of Health and Human Services. The Globalization of Clinical Trials: A Growing Challenge in Protecting Human Subjects. 2001. Boston, MA, Office of Evaluation and Inspections.
  2. de Zulueta P. Randomised placebo-controlled trials and HIV-infected pregnant women in developing countries. Ethical imperialism or unethical exploitation? Bioethics 2001;15(4):289-311.
  3. Bayer R. The debate over maternal-fetal HIV transmission prevention trials in Africa, Asia, and Caribbean: racist exploitation or exploitation of racism? American Journal of Public Health 1998;88(4):567-70.
  4. Crouch RA, Arras JD. AZT trials and tribulations. Hastings Center Report 1998;28(6):26-34.
  5. National Bioethics Advisory Commission. Ethical and Policy Issues in International Research: Clinical Trials in Developing Countries. 2001. Bethesda, MD, National Bioethics Advisory Commission.
  6. Council for International Organizations of Medical Sciences. The Draft CIOMS Guidelines. 2001. Geneva, Switzerland, CIOMS.
  7. Benatar SR. Distributive justice and clinical trials in the Third World. Theor Med Bioeth 2001;22(3):169-76.
  8. Ijsselmuiden CB, Faden RR. Research and informed consent in Africa---another look. New England Journal of Medicine 1992;326(12):830-4.
  9. Browner CH, Preloran M, Cox SJ. Ethnicity, bioethics, and prenatal diagnosis: the amniocentesis decisions of Mexican-origin women and their partners. American Journal of Public Health 1999;89:1658-66.
  10. Karim QA, Karim SSA. Informed consent for HIV testing in a South African hospital: is it truly informed and truly coluntary? American Journal of Public Health 1998;88(4):637-40.
  11. Coreil J, Losikoff P, Pincu R, Mayard G, Ruff AJ, Hausler HP et al. Cultural feasibility studies in preparation for clinical trials to reduce maternal-infant HIV transmission in Haiti. AIDS Education and Prevention 1998;10(1 ):46-62.
  12. Featherstone K, Donovan JL. "Why don't they just tell me straight, why allocate it?" The struggle to make sense of participating in a randomised controlled trial. Social Science & Medicine 2002;55:709-19.
  13. Weijer C, Emanuel EJ. Protecting communities in biomedical research. Science 2000;289:1142-4.
  14. London AJ. The ambiguity and the exigency: clarifying 'standard of care' arguments in international research. Journal of Medicine and Philosophy 2000;25:379-97.